The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,200
- Locations
- 1
- Primary Endpoint
- To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative .
Detailed Description
Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative. HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.
Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.
This is a randomized, blind phase 3 clinical trial. Total 1200 adults (above ages 36 months ) were selected, randomized to two groups [Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600], adults in each group will be vaccinated with one dose of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 36 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males and females, age above 36 months ;
- •Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
- •Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
- •Infants no vaccinated with influenza or other preventive biologicals in recent 7 days;
- •Axillary temperature ≤37℃.
Exclusion Criteria
- •Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy;
- •Low platelet or bleeding disorder do not allow vaccination into the muscle;
- •Have damaged or lower immunological function;
- •Received blood, plasma or immunoglobulin treatment since birth;
- •Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
- •Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
Arms & Interventions
Influenza Virus Vaccine
Influenza Virus Vaccine（no Preservative ) 0.5ml intramuscular injections
Intervention: Influenza Virus Vaccine(contains Preservative) (Biological)
Influenza Virus Vaccine(Preservative)
Influenza Virus Vaccine（add Preservative ) 0.5ml intramuscular injections
Intervention: Influenza Virus Vaccine(contains Preservative) (Biological)
Influenza Virus Vaccine
Influenza Virus Vaccine（no Preservative ) 0.5ml intramuscular injections
Intervention: Influenza Virus Vaccine (Biological)
Influenza Virus Vaccine(Preservative)
Influenza Virus Vaccine（add Preservative ) 0.5ml intramuscular injections
Intervention: Influenza Virus Vaccine (Biological)
Outcomes
Primary Outcomes
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)
Time Frame: six months
Secondary Outcomes
No secondary outcomes reported